BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 4180337 · Received October 15, 2014

    Report

    Report Number
    3009897021-2014-00127
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 16, 2014
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE NECROTIC TISSUE OR POCKET INCISION IS RELATED TO V.A.C. THERAPY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: ON (B)(6) 2014, V.A.C. THERAPY WAS APPLIED TO THE PATIENT'S BACK AND SACRAL PRESSURE ULCER USING THE BRIDGING TECHNIQUE. ON (B)(6) 2014, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT OF THE PATIENT'S PRESSURE ULCERS OF THE LOWER LIMBS, SACRUM AND BACK. THE PATIENT EXPERIENCED A "POCKET OF THE SACRAL PRESSURE ULCER [THAT] WAS INCISED AND CHANGED TO PRE-EXISTING TREATMENT DUE TO NECROTIC TISSUE." THE PATIENT ALSO EXPERIENCED A "POCKET" ON THE BACK PRESSURE ULCER, AND A POCKET INCISION WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THUS KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655707 V.A.C. THERAPY OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention